Which is better, PT-141 (bremelanotide) or Melanotan II?
PT-141 is FDA approved and graded human RCT from the RECONNECT phase 3 program, though the effect on desire is small (0.30 to 0.42 points on the FSFI desire domain) and its clinical meaningfulness has been questioned. Melanotan II is also graded human RCT, but only from two tiny crossover trials in the 1990s, and it has no approved use, no lawful compounding basis after its Category 2 nomination was withdrawn, and published case reports of serious harm. Both act on melanocortin receptors, but only one has a regulated product, a label, and phase 3 safety data. [1] [2] [3] [4] [5] [6]
How do PT-141 (bremelanotide) and Melanotan II compare?
| Dimension | PT-141 (bremelanotide)Favored | Melanotan II |
|---|---|---|
| What it is [3] [4] | Cyclic heptapeptide MC4R and MC3R agonist; an active metabolite of Melanotan II. | Cyclic heptapeptide alpha-MSH analog; nonselective agonist at MC1R, MC3R, MC4R, and MC5R. |
| Receptor profile and effects [3] [4] [7] | Acts centrally on MC4R and MC3R to increase sexual desire; only minor MC1R effects (focal hyperpigmentation in about 1%). | Strong MC1R activation causes tanning and darkening of moles, while MC4R activation causes erections, reduced appetite, and yawning. |
| Human evidence [1] [4] [5] [8] [9] | Two phase 3 randomized trials (RECONNECT, 1,267 premenopausal women, 24 weeks) plus a 52 week extension; smaller intranasal trials in men, including sildenafil non-responders. | Two double-blind crossover trials of 10 men each with erectile dysfunction (1998, 2000): erections in 8 of 10 men and after 12 of 19 injections versus 1 of 21 placebo doses. No tanning trial. |
| Effect size [1] [2] [4] | Desire rose 0.30 and 0.42 points versus placebo and distress fell 0.37 and 0.29 points; a 2024 reanalysis argued these changes are below thresholds for clinical meaningfulness. | Tip rigidity above 80% lasted 38 minutes versus 3 minutes with placebo in psychogenic erectile dysfunction. |
| Safety [3] [5] [6] [7] [10] [11] | Nausea in about 40%, flushing about 20%, headache about 11%; transient blood pressure rise of about 6 mmHg systolic after each dose; label limits use to 8 doses per month. | Severe nausea after 4 of 19 injections in trials; case reports of eruptive and darkening moles within 24 hours, priapism, renal infarction, and FDA cited reports of melanoma and posterior reversible encephalopathy syndrome. |
| FDA status [3] [6] | FDA approved as Vyleesi (June 2019) for acquired, generalized hypoactive sexual desire disorder in premenopausal women; use in men is off label. | Not approved in any country. Its Category 2 nomination was withdrawn, but it is not on the bulks list and not an approved drug component, so a 503A pharmacy has no basis to compound it. |
| Dosing in the label or literature [3] [4] | Vyleesi: 1.75 mg subcutaneously at least 45 minutes before sexual activity, no more than once in 24 hours or 8 times per month. | Single 0.025 mg/kg subcutaneous doses in the two trials; no repeat dose or tanning regimen has been studied. |
| WADA status [12] [13] | Not on the WADA Prohibited List. | Prohibited at all times under S0 (non-approved substances). |
| Cost and access [3] [6] [14] | Vyleesi list price roughly 900 USD per carton of four autoinjectors, about 99 USD with a copay program for commercially insured patients; compounded PT-141 roughly 100 to 300 USD per vial or spray. | No lawful channel. Gray market tanning vials have been found unsterile or mislabeled. |
Evidence grade and regulatory status
Pulled from each peptide’s own record, so it stays in step with the peptide pages.
| Attribute | PT-141 (bremelanotide) | Melanotan II |
|---|---|---|
| Class | Cyclic heptapeptide melanocortin receptor agonist (MC4R and MC3R), an active metabolite of Melanotan II | Synthetic cyclic heptapeptide analog of alpha-melanocyte stimulating hormone; nonselective melanocortin receptor agonist (MC1R, MC3R, MC4R, MC5R) |
| What it is | FDA approved (Vyleesi, 2019) for low sexual desire in premenopausal women; effect is small and nausea affects about 40% of users. | Unapproved tanning and libido injection with two tiny 1990s erection trials, case reports of melanoma and prolonged erections, and no lawful source. |
| Evidence | Evidence: Human RCT evidence | Evidence: Human RCT evidence |
| FDA status | Regulatory: FDA approved | Regulatory: Removed from Category 2 (Apr 2026) |
| Compounding | FDA approved as Vyleesi (bremelanotide injection) on June 21, 2019, for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Because bremelanotide is the active ingredient of an approved drug, some 503A pharmacies compound it under the approved drug component pathway, but compounded PT-141 vials and nasal sprays are not FDA approved formulations, have not been tested for potency or sterility by FDA, and the nasal route was abandoned by the sponsor over blood pressure effects. Use in men is off-label. | Melanotan II was placed on the FDA 503A Category 2 list (substances that may present significant safety risks) with FDA citing immunogenicity risk, peptide impurities, and published case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and priapism. As of the FDA page current to April 22, 2026, its nomination has been withdrawn, so it no longer sits in Category 2, but it is not on the 503A bulks list, was not among the peptides the Pharmacy Compounding Advisory Committee took up in July 2026, and is not a component of any approved drug. A 503A pharmacy therefore has no basis to compound it. It is not approved as a drug in any country. |
| WADA | WADA: Not WADA prohibited | WADA: WADA prohibited |
| Routes | Subcutaneous injection by autoinjector, on demand (Vyleesi), Intranasal (discontinued development program for men), Compounded subcutaneous vials and nasal sprays (not FDA approved formulations) | Subcutaneous injection (trials and as sold), Nasal spray (as sold; no studies), Products labeled research use only are not lawful for human use |
| Typical cost | Vyleesi retail cash prices run about 930 to 956 USD per carton of four autoinjectors; the manufacturer savings program lists 0 USD for most commercially insured patients and 99 USD per carton without coverage. Compounded PT-141 nasal spray through a licensed telehealth program is about 187 to 224 USD per month. Prices checked 2026-09-22 and change often. | Not available through licensed channels. Gray market vials are sold online for tanning, but those products are not lawful for human use and have been found unsterile or mislabeled. |
| Last verified |
Has PT-141 (bremelanotide) been tested directly against Melanotan II?
No published trial has compared PT-141 (bremelanotide) and Melanotan II directly. The dimensions above come from separate studies and labels, and cross-trial comparisons are less reliable than a direct trial.
What do PT-141 (bremelanotide) and Melanotan II cost?
| Dimension | PT-141 (bremelanotide) | Melanotan II |
|---|---|---|
| Typical cost | $187 to $224 per month | Not available through licensed channels. Gray market vials are sold online for tanning, but those products are not lawful for human use and have been found unsterile or mislabeled. |
| Price detail | PT-141 (bremelanotide) price by channel | Price index in progress |
Where a price index exists, the range is the cash price per month across branded, compounded, and telehealth channels, without insurance. The cost pages give each channel separately with its sources. Otherwise the typical cost from the peptide record is shown. Legal access depends on your state: see peptide legality by state.
Frequently asked questions
Is PT-141 the same as Melanotan II?
No, but they are related. Bremelanotide (PT-141) is an active metabolite of Melanotan II that was developed separately and approved as Vyleesi. It acts mainly on the brain receptors involved in desire, while Melanotan II also strongly activates the skin pigment receptor. [3] [4]
Which works better for erectile dysfunction?
Neither is approved for men. Both produced erections in small placebo controlled trials, including intranasal PT-141 in men who had failed sildenafil. PDE5 inhibitors remain the standard, and PT-141 use in men is off label. [5] [9] [15]
Will PT-141 give me a tan like Melanotan II?
No meaningful tan. The Vyleesi label reports focal darkening of the face, gums, or breasts in about 1% of users, more often with frequent dosing. Melanotan II causes whole body tanning and can darken moles or cause new ones within a day. [3] [7]
Is Melanotan II legal?
Not for human use in the United States. It is not approved anywhere, and although its Category 2 nomination was withdrawn, it is not on the 503A bulks list or a component of an approved drug, so pharmacies have no basis to compound it. FDA has cited case reports of melanoma, encephalopathy, and priapism. [6] [10]
What are the main risks of PT-141?
Nausea is the most common effect (about 40% in trials, mostly after the first dose), followed by flushing and headache. Blood pressure rises briefly after each dose, so it is not for people with uncontrolled hypertension or cardiovascular disease, and it lowers absorption of oral naltrexone. [1] [3]
Conditions studied
From the blog
- Sildenafil vs Viagra: same drug, generic vs brand
Sildenafil is the active ingredient in Viagra. How generic sildenafil compares, why 20 mg tablets are labeled for pulmonary hypertension, the label side effects, and the nitrate contraindication.
- Melanotan 2 before and after: what trials and case reports show
Melanotan 2 before and after photos show a tan. Early trials measured it in a few men; case reports since document new moles, melanoma, priapism and FDA safety concerns.
- Peptides for men, ranked by human evidence
hCG, GLP-1 drugs, teriparatide, and tesamorelin have human trials and a lawful route. PT-141 is off-label for men, and kisspeptin and melanotan II have no lawful path. Ranking, legality, and WADA.
Sources
Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.
- [1]Kingsberg SA et al. Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials. Obstet Gynecol 2019 (RECONNECT)PubMed 31599840, 2019
- [2]Spielmans GI. Small effects, questionable outcomes: bremelanotide for hypoactive sexual desire disorder. J Sex Res 2024PubMed 36809187, 2024
- [3]FDA prescribing information for Vyleesi (bremelanotide injection), via DailyMedFDA, 2025
- [4]Wessells H et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol 1998PubMed 9679884, 1998
- [5]Wessells H et al. Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction. Urology 2000PubMed 11018622, 2000
- [6]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
- [7]Schulze F et al. Eruptive naevi and darkening of pre-existing naevi 24 h after a single mono-dose injection of melanotan II. Eur J Dermatol 2014PubMed 24334249, 2014
- [8]Simon JA et al. Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder. Obstet Gynecol 2019PubMed 31599847, 2019
- [9]Safarinejad MR, Hosseini SY. Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study. J Urol 2008PubMed 18206919, 2008
- [10]Dreyer BA et al. Melanotan-induced priapism: a hard-earned tan. BMJ Case Rep 2019PubMed 30796078, 2019
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<a href="https://peptideagent.ai/compare/pt-141-vs-melanotan-ii">PT-141 (bremelanotide) vs Melanotan II: evidence, cost, and legality</a>, PeptideAgent, updated September 22, 2026.